Federal Register notice: FDA makes available a guidance on Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding ...
Federal Register notice: FDA makes available a guidance entitled Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Pro...
FDA grants PellePharm a breakthrough therapy designation and orphan drug designation for topical patidegib for patients with Gorlin Syndrome.
A new White House report estimates that the ongoing opioid crisis cost the U.S. $504 billion in 2015 and led to over 33,000 American overdose deaths.
Federal Register notice: FDA acknowledges that an applicant for a proposed biosimilar product notified the agency that a patent infringement action wa...
Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Direct Marking of Devices.
FDA approves a Kalo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reactions, including anaph...
FDA Review posts the Federal Register notices for the week ending 11/17/2017.